We are looking for a team member on a consultancy/freelance basis for 2-3 years:

Responsibilities

You are responsible for the end-to-end coordination of the commissioning phase across all facility systems – building, process, and utilities – ensuring that integrated handover to operations is achieved safely, on schedule, and in full compliance with GMP and nuclear regulatory requirements (including a strict commissioning plan involving the nuclear regulator).

Commissioning sequencing & planning

- Own and maintain the master commissioning sequence, defining the order of system acceptance, integrated testing milestones, and handover gates across all workstreams
- Work in close alignment with the Planning Engineer to ensure commissioning activities are fully integrated into the overall project schedule
- Identify and manage interdependencies between building systems (HVAC, electrical, civil) and process systems (irradiation, downstream processing, dispensing), in close collaboration with the various Project Managers

Integration & cross-system coordination

- Lead the design and execution of integrated and cross-system testing that spans multiple project manager scopes
- Ensure that building and process systems are validated under representative operating conditions before operational handover
- Coordinate the involvement of equipment vendors, third-party qualified persons, and regulatory bodies (including FANC) during commissioning activities
- Integrate change management process, ensuring that changes are properly documented, reviewed, approved, and reflected throughout the commissioning activities.

Gate enforcement & commissioning register

- Maintain the commissioning register, tracking acceptance status across all systems and subsystems




- Enforce readiness gates: no system proceeds to integrated testing before individual acceptance by the responsible project manager is complete and documented
- Escalate unresolved blockers directly to project leadership
- Contribute to the preparation and/or review of FAT protocols as needed

Handover to operations

- Act as the primary interface between the project team and the operations team during the commissioning and handover phase
- Ensure commissioning documentation is complete, traceable, and fit for purpose as regulatory records supporting qualification and future submissions (DMF, IMPD)
- Ensure commissioning documentation and data are structured so they can be easily transferred into the CMMS.
- Support a clean, documented transfer of each system to the Operations Manager
- Anticipate involvement of Operations in the commissioning phase to facilitate transfer to operation phase

Safety

- Daily follow-up of on-site activities involving live systems, with close communication with the construction team.
- Critical review of method statements for work on live systems, or in areas close to live systems, in close coordination with the construction team and the contractor.
- LOTO(TO) management to safeguard live systems between construction phases or during change management activities (when applicable).

Profile





- You have 10–15 years of experience in industrial project environments, with a significant portion dedicated to commissioning roles in regulated industries (pharmaceutical, nuclear, or equivalent)
- You have directly led or been a senior member of a commissioning team on at least one major facility or process line, with hands-on experience in IQ/OQ/PQ workflows, FAT/SAT sequences, and commissioning documentation
- You think in systems: you understand how HVAC, electrical, process, and control systems interact, and you instinctively look for integration risks across discipline boundaries
- You are technically credible across multiple engineering domains without needing to be the deepest expert in any single one
- You hold your ground under schedule pressure — you are capable of enforcing gates and escalating when necessary, with the personal authority to make it stick
- Experience in a GMP-regulated environment is required; familiarity with nuclear licensing and radiation protection constraints is a strong asset
- You are comfortable operating as a coordination hub in a multi-contractor, multi-stakeholder environment without formal authority over most of the people you work with
- You are fluent in English; French and/or Dutch is an asset in our Belgian operational context

You are also

- Rigorous and structured, but pragmatic enough to keep things moving in a dynamic project environment
- A natural integrator - your instinct is to connect and align, not to own and control
- Comfortable with ambiguity during a scale-up phase where not everything is defined in advance
- Genuinely motivated by the mission: enabling the supply of life-saving radiopharmaceuticals at scale

📌 Commissioning lead (España)
🏢 Pantera
📍 España